A randomized, double-blind, placebo-controlled exploratory trial to evaluate a one-week oral treatment with R129160 (60 mg o.d.) in patients with chronic idiopathic urticaria - oral treatment with R129160 (60 mg o.d.) in patients with chronic idiopathic urticaria

• Conditions: Chronic Idiopathic Urticaria

• Registration Number: EUCTR2005-002749-38-BE
• Lead Sponsor: Barrier Therapeutics nv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1.Subjects, male or female, aged between 18 and 65 (extremes included)
2.Women of childbearing potential must have a negative urine pregnancy test at screening, must have used a highly effective stable form of birth control (with a failure rate of less than 1%) for at least one month prior to screening and must agree to remain on this effective form of birth control until the first menses after 30 days following the end of study medication treatment. This effective form of birth control consists of oral contraceptives or a contraceptive implant or a depot injection or a contraceptive patch or an IUD.
3.In addition, women of childbearing potential should use a double barrier method (one of the methods mentioned above under item 6 together with a condom and spermicidal agent or a diaphragm and spermicidal agent) from inclusion up to 7 days after end of treatment.

4.Confirmed diagnosis of CIU, with history of signs and symptoms for at least 3 days/week during more than 6 consecutive weeks in the 12 months preceding Visit 1, with active disease at the time of inclusion
5.During run-in period (from Visit 1 to Visit 2), pruritus and wheals present for at least 2 days
6.At least moderate pruritus (score of 2 or more) and wheals present (score of 1 or more) during the previous 12 hours
7.Ability to assess their symptom scores accurately and to complete the diary
8.Availability of signed informed consent prior to beginning clinical trial protocol-specific procedures, indicating an understanding of the purpose of this trial and a willingness to adhere to the treatment regimen and trial procedures described in this clinical trial protocol
9.In good general health and free of any disease state or physical condition which, in the investigator’s opinion, exposes the subject to an unacceptable risk by trial participation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

erythematosus, hepatitis, vasculitis, hyperthyroidism), with physical urticaria (cold, heat, sun-induced, pressure or dermographism, aquagenic), with cholinergic urticaria, with hereditary angioedema or with urticaria due to medications, insect bites, food or any other known etiology
2.Subjects, previously unresponsive to at least two different antihistamines for the treatment of chronic idiopathic urticaria
3.History of drug allergy to antihistamines, other anti-allergic compounds, quinine or any of the components of the trial medication
4.History or suspicion of alcohol and/or drug abuse
5.Subjects having following concomitant disorders: significant hepatic, renal or bone marrow diseases, severe neuropathy including multiple sclerosis, significant psychiatric disorders or any other serious disease (including cancer and subjects known to be HIV positive), significant infection that requires systemic antibiotic treatment
6.Subjects previously randomized in the trial.
7.Any disease state or physical condition that, in the investigator’s opinion, may impair evaluation of itch and/or the urticaria, or may interfere with the treatment
8.Any disease state or surgery known to affect the GI absorption of drugs
9.Out-of-range laboratory test results that the investigator considers as pathologic
10.History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
11.Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males
12.Use of following medication, unless discontinued at Visit 1: oral and/or topical antihistaminic compounds, including H2 antagonists (exception for Hismanal®: discontinued for at least 4 weeks before Visit 2); topical corticosteroids; topical immuno-modulating agents; other topical and/or systemic anti-allergic or anti-pruritic agents; non steroidal anti-inflammatory drugs (NSAIDs)
13.Use of sedatives or hypnotics within 7 days prior to Visit 1
14.Use of oral corticosteroids; oral immuno-modulating agents; antidepressants, antipsychotics or tranquillizers within 21 days prior to Visit 1
15.Use of intramuscular or intra-articular corticosteroids 90 days prior to Visit 1
16.Pregnant or breastfeeding women, or women of childbearing potential not using adequate contraceptives.
17.Received another investigational drug within the 30 days prior to entry into the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate effect of the IMP on the itch, associated wit Chronic Idiopatic Urticaria;Secondary Objective: Evaluate the effect of the IMP on the Chronic idiopatic Urticaria lesions;Primary end point(s): For each treatment arm, the change in the average itch severity score over the one week treatment period relative to baseline is summarized as mean, median, standard deviation, range, and distribution-free 95% confidence intervals for the median for both the intention-to-treat and per-protocol population.